CSV Consultant

Job Listing No: 9740000

CSV Consultant

Ireland – Job Summary: I’m currently looking for a CSV consultant to work on a data integrity project with a medical device company in Belgium. They are looking to hire an SME in data integrity processes according to the FDA guidelines that were issues in 2016. They are a medical devices (cardiac, surgical) manufacturer with 3 production sites, own distribution centre, 2 central labs, clinical dept. and sales/marketing divisions. All division systems to be included in this project implementation. The 1st phase of the project would be a Gap Assessment for data integrity FDA compliance of all systems. The 2nd phase is to validate all the CSV systems 21 CFR part 11 guidelinesand the 3rd phase would be to provide training/mentoring on implementation of best practice for these guidelines for the company to remain compliant. Berkley Engineering is a specialist recruitment consultancy which recruits pharmaceutical, medical device and clinical professionals throughout Ireland, Europe, Asia and A… – Permanent – Full-time

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